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A Phase II/III, Open-Label, Multi-Center Clinical Trial to Evaluate the Safety and Efficacy of Insulin-Like Growth Factor I/ Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3), Administered for 12 Months in Children and Adolescents with Growth Hormone Insensitivity Syndrome (GHIS) such as Laron Syndrome.

A Phase II/III, Open-Label, Multi-Center Clinical Trial to Evaluate the Safety and Efficacy of Insulin-Like Growth Factor I/ Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3), Administered for 12 Months in Children and Adolescents with Growth Hormone Insensitivity Syndrome (GHIS) such as Laron Syndrome.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000644-25-SK
Enrollment
40
Registered
2004-06-02
Start date
2004-07-09
Completion date
Unknown
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Insensitivity Syndrome (GHIS) is a genetically disturbance of the biological action of growth hormone (GH). This study is intended to evaluate the ability of rhIGF-I/rhIGFBP-3 to demonstrate height velocity increases, in pre-pubertal children with GHIS and to evaluate the safety profile of extended treatment with rhIGF-I/rhIGFBP-3, believed to be more favorable that that observed with rhIGF-I.

Interventions

Product Name: MECASERMIN RINFABATE Product Code: rhIGF-I/rhIGFBP-3 Pharmaceutical Form: Solution for injection INN or Proposed INN: MECASERBIN RINFABATE Other descriptive name: rhIGF-I/rhIGFBP-3 Conce

Sponsors

Insmed Incorporated
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: See protocol page 12. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: See protocol page 12.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the safety, tolerability and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in prepubertal children and adolescents with GHIS. ;Secondary Objective: None.;Primary end point(s): Change in Height Velocity (HV) from baseline.—

Countries

Italy, Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026